Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 主要终点
- TSIH
研究概览
简要总结
TITLE:
Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in patients with risk factors.
OBJECTIVE: To evaluate whether the placement of a synthetic prosthesis with omega-3 in its composition at the level of the umbilical trocar after laparoscopic cholecystectomy versus the placement of a synthetic umbilical prosthesis without omega-3 in its composition decreases the rate of surgical site infection (SSI) and trocar site hernia (TSH) in patients with risk factors for infection and herniation.
详细描述
METHODS: A prospective study was conducted with 2 consecutive series of patients operated on for cholelithiasis who also had some of the following risk factors that increase the occurrence of SSI or TSH: BMI > 30 kg/m2, diabetes mellitus, age > 65 years and chronic obstructive pulmonary disease. A circular prosthesis with an omega-3 coating was placed in patients in group A, and a prosthesis without omega-3 in its composition was placed in patients in group B. The main variables evaluated were the occurrence of SSI and TSH.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The included patients were between the ages of 18 and 90 years, underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors that increase the occurrence of SSI or TSIH:
- •Obesity: with a body mass index (BMI) > 30 kg/m
- •Diabetes Mellitus (insulin dependent or who take oral antidiabetic drugs),
- •Age > 65 years and
- •COPD treated with inhalers.
排除标准
- •Nonfulfillment of the inclusion criteria.
- •Conversion to laparotomy during the surgical procedure
- •Non-acceptance of participation in the study by the patient
- •Loss to follow-up.
结局指标
主要结局
TSIH
时间窗: 1 year
Trocar site incisional hernia.
SSI
时间窗: 1 year
Surgical Site Infection.
次要结局
未报告次要终点
研究者
Marta Bellón
FISABIO
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana